[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"scaphoid-fracture\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:scaphoid-fracture":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100483403","arthroscopic-vs-open-bone-grafting-for-scaphoid-delayednonunion-100483403",false,"NCT05574582","Arthroscopic vs. Open Bone Grafting for Scaphoid Delayed\u002FNonunion","Arthroscopic Versus Open Cancellous Bone Grafting for Scaphoid Delayed\u002FNon-union in Adults: Study Protocol for a Randomized Clinical Trial","Inclusion Criteria:\n\n1. Patients aged 18-68 years.\n2. A scaphoid fracture without healing 2-6 months since fracture (delayed union) for cases with either displacement \\>1mm or comminution and failed non-operative treatment.\n3. Scaphoid fracture without healing \\>6 months since fracture (non-union) regardless of displacement, comminution and if previous non-operative treatment has been tried.\n4. ASA 1-3.\n\nExclusion Criteria:\n\n1. Open fractures\n2. Associated trans-scaphoid perilunate dislocation.\n3. Associated fracture in the hand\u002Fupper extremity.\n4. Previous failed surgical treatment for scaphoid delayed\u002Fnon-union.\n5. Stage 2 SNAC or above.\n6. Avascular necrosis of the proximal pole as evaluated with MRI and absence of punctate bleeding intraoperatively.\n7. Patients with gross humpback deformity of HLR \\>0.75 and\u002For DCA \\\u003C70⁰.\n8. Patients unable to understand instructions in Danish, complete the rehabilitation protocol, or answering the questionnaires because of physical or cognitive impairment, as evaluated by the surgeon at the first visit.","ALL","18 Years","68 Years",{"count":20,"type":21},88,"ESTIMATED","INTERVENTIONAL",[24],"NA","Single site, prospective, observer-blinded randomized controlled trial. Eighty-eight patients aged 18-68 years with scaphoid delayed\u002Fnon-union, will be randomized, 1:1, to either open iliac crest cancellous graft reconstruction or arthroscopic assisted distal radius cancellous chips graft reconstruction. All Danish citizens, referred to the orthopedic department, Copenhagen University Hospital in Gentofte with scaphoid delayed\u002Fnonunion will be offered participation in the trial. Exclusion criteria are: Associated fracture in the hand\u002Fupper extremity, previous failed surgical treatment for scaphoid delayed\u002Fnonunion, stage 2 SNAC or above, avascular necrosis of the proximal pole and gross deformity.\n\nPatients are stratified for smoking habits, proximal pole involvement, and displacement of \\>\u002F\\\u003C2mm. The primary outcome is time to union, measured with repeated CT scans at 2-week intervals from 6 to 16 weeks postoperatively. Secondary outcomes are Quick disabilities of the Arm, Shoulder and Hand (Q-DASH), Visual Analogue scale (VAS), donor site morbidity, union rate, restoration of scaphoid deformity, range of motion, key-pinch, grip strength, EQ5D-5L, patient satisfaction, complications, and revision surgery. Patients are examined before the operation and 1.5, 3, 6, 12 and 24 month after the operation. Online follow-up 5 and 10 years after surgery are performed.",[27,28],"Scaphoid Fracture","Scaphoid Nonunion",[30,31,32,33,34,35],"Scaphoid","Scaphoid nonunion","Cancellous","Graft","Arthroscopic","Timo to union","RECRUITING","2023-02-28",{"date":39,"type":40},"2023-03-01","ACTUAL",{"date":42,"type":40},"2023-02-15",{"date":44,"type":21},"2028-01-01",{"name":46,"class":47},"Herlev and Gentofte Hospital","OTHER"]